BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16582863 · Received March 21, 2023

    Report

    Report Number
    2210968-2023-01854
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    November 30, 2021
    Report Date
    March 21, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 3/21/2023. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ADVERSE EVENT PROBLEM COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: LANGENBECK¿S ARCHIVES OF SURGERY (2022) 407:1263¿1269; HTTPS://DOI.ORG/10.1007/S00423-021-02384-6.

    Description of Event or Problem · 0

    TITLE: CLINICAL IMPACT OF THE NEW ¿TWIN U-STITCH METHOD¿ OF PANCREATICOGASTROSTOMY IN PANCREATICODUODENECTOMY. THIS RETROSPECTIVE REVIEW AIMED TO EVALUATE THE CLINICAL IMPACT OF THE ¿TWIN U-STITCH METHOD¿ AND COMPARED IT WITH THE CONVENTIONAL INVAGINATION METHOD. BETWEEN JANUARY 2015 AND NOVEMBER 2020, 183 PATIENTS WHO UNDERWENT PANCREATICOGASTROSTOMY AFTER PANCREATICODUODENECTOMY WERE INCLUDED IN THE STUDY. PATIENTS FOR WHOM CONVENTIONAL PANCREATICOGASTROSTOMY WAS PERFORMED FROM 2015 TO 2018 COMPRISED THE CONVENTIONAL PG GROUP, AND THE REMAINING PATIENTS FOR WHOM THE TWIN U-STITCH METHOD WAS PERFORMED FROM 2018 TO 2020 COMPRISED THE TWIN U-STITCH GROUP. IN THE TWIN U-STITCH GROUP, THERE WERE 97 PATIENTS COMPOSED OF 58 MALES AND 39 FEMALES WITH A MEAN AGE OF 71 YEARS (RANGE, 31-87) AND A MEAN BMI OF 22.6 KG/M2 (RANGE, 20.7-24.9). IN THE CONVENTIONAL PG GROUP, THERE WERE 86 PATIENTS COMPOSED OF 55 MALES AND 31 FEMALES WITH A MEAN AGE OF 71 YEARS (RANGE, 36-90) AND A MEAN BMI OF 22.2 KG/M2 (RANGE, 20.5-24.9). PATIENTS IN THE TWIN U-STITCH GROUP UNDERWENT PANCREATICOGASTROSTOMY USING A COMPETITOR DOUBLE-ARMED NON-ABSORBABLE SUTURE (MANUFACTURER: ASFLEX). PATIENTS IN THE CONVENTIONAL PG GROUP UNDERWENT PANCREATICOGASTROSTOMY USING A NON-ABSORBABLE POLYESTER FILAMENT 4-0 ETHIBOND (ETHICON). THE MEDIAN FOLLOW-UP INTERVAL WAS 751 DAYS (RANGE, 23¿2257). THE REPORTED COMPLICATIONS INCLUDED LEAKAGE OF POSTOPERATIVE PANCREATIC FISTULA (N=18), BLEEDING OF THE STUMP (N=1), AND ABSCESS (N=1). IN CONCLUSION, THE TWIN U-STITCH METHOD WAS SIMPLE AND PREFERABLE TO THE CONVENTIONAL METHOD FOR PREVENTING PANCREATIC FISTULA IN PATIENTS WITH PANCREATICODUODENECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11505 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other